EMBOLIC PROTECTION DEVICE AND METHOD OF USE

• US 20100168785A1
• Filed: 12/29/2008
• Published: 07/01/2010
• Est. Priority Date: 12/29/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Parker, Fred T.
• Granted Patent: US 8,388,644 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool

Abstract

A medical device for embolic protection within a patient'"'"'s body vessel is provided. The device comprises inner and outer tubular members each having proximal and distal ends and a lumen formed through the proximal and distal ends. A flexible everting filter portion includes a body having a first end attached to the distal end of the inner tubular member and a second end attached to the distal end of the outer tubular member. The inner and outer tubular members are movable relative to one another to position the filter portion within the body vessel. The filter portion is movable from a collapsed, everted delivery and removal configuration to an expanded, generally non-everted deployed configuration. The filter portion expands radially outward to engage the filter body with an enclosing vessel wall. The filter portion allows the passage of blood cells and prevents the passage of emboli or thrombi through the body vessel.

Claims

1. A medical device for embolic protection within a patient'"'"'s body vessel, the medical device comprising:

an outer catheter having a proximal end and a distal end, the outer catheter having an outer lumen formed through the proximal and distal ends defining a proximal opening at the proximal end and a distal opening at the distal end of the outer catheter;

an inner catheter movable within the outer catheter and having a proximal end and a distal end, the inner catheter having an inner lumen formed through the proximal and distal ends defining a proximal opening at the proximal end and a distal opening at the distal end of the inner catheter; and

a flexible filter portion having a body extending from a first end to a second end, the first end being attached to the distal end of the inner catheter and the second end being attached to the distal end of the outer catheter, the outer catheter and the inner catheter movable relative to one another to move the filter portion between a collapsed state for delivery and removal of the device and an expanded state for engaging the filter body with a body vessel wall, the distal end of the inner catheter being arranged proximal to the distal end of the outer catheter such that the filter body is everted and defines a distal cavity within the distal end of the outer catheter in the collapsed state, the distal end of the inner catheter being movable distal to the distal end of the outer catheter such that the filter body is generally non-everted and defines a cylindrical body extending distally from the distal end of the outer catheter in the expanded state, the distal ends of the outer catheter and the inner catheter being longitudinally separated by approximately the length of the filter body in the collapsed state and in the expanded state.

2. The medical device of claim 1, wherein the filter body includes an opening at the first end and a proximally facing concave surface adjacent the second end in the collapsed state, the proximally facing concave surface defining the distal cavity and the opening providing fluid communication between the inner catheter lumen and the distal cavity.

3. The medical device of claim 1, wherein the filter body includes an opening at the second end and a proximally facing concave surface adjacent the first end in the expanded state, the proximally facing concave surface defining an interior of the filter portion and the opening providing fluid communication between the outer catheter lumen and the interior of the filter portion.

4. The medical device of claim 3, wherein the inner catheter is disposed within the interior of the filter portion in the expanded state.

5. The medical device of claim 1, further comprising an elongate instrument movable longitudinally within the inner catheter lumen relative to the inner catheter and extendible through the proximal and distal openings of the inner catheter.

6. The medical device of claim 1, wherein the filter portion includes a plurality of elements defining a plurality of openings sized to allow blood cells to pass through the filter openings and prevent the passage of emboli.

7. The medical device of claim 1, wherein the filter portion includes a porous expandable mesh structure.

8. The medical device of claim 7, wherein the mesh structure is constructed from a material selected from the group consisting of polyester, nylon, Dacron, thorolon, ePTFE, stainless steel, nickel-titanium alloys, and cobalt-base alloys.

9. The medical device of claim 1, wherein the filter portion includes at least one radiopaque marker to assist in monitoring deployment of the filter portion.

10. The medical device of claim 1, wherein the device is positioned within a branched vessel such that the filter portion in the expanded state is longitudinally disposed within a first lumen of the branched vessel and transversely disposed relative to a second lumen of the branched vessel, wherein the filter portion allows blood cells to pass through the first lumen and into the second lumen and prevents emboli from entering the second lumen.

11. A medical device for capturing emboli in a patient'"'"'s body vessel, the medical device comprising:

an elongate outer tubular member and an elongate inner tubular member movable within the outer tubular member, each of the outer and inner tubular members having a proximal end and a distal end and a lumen formed through the proximal and distal ends defining a proximal opening at the proximal end and a distal opening at the distal end; and

a flexible everting filter portion having a body extending from a first end to a second end, the first end being attached to the distal end of the inner tubular member and the second end being attached to the distal end of the outer tubular member, the filter portion movable between a collapsed insertion and removal configuration and an expanded deployed configuration, the filter portion being compressed in an everted state within the distal end of the outer tubular member in the collapsed configuration, the inner and outer tubular members being movable relative to one another to distally extend the filter portion from the outer tubular member, the filter portion being biased to expand radially outward to engage the filter body with an enclosing body vessel wall in the expanded configuration.

12. The medical device of claim 11, wherein the first end of the filter portion attached to the distal end of the inner tubular member is arranged proximal to the second end of the filter portion attached to the distal end of the outer tubular member defining an everted distal cavity in the collapsed configuration.

13. The medical device of claim 11, wherein the first end of the filter portion attached to the distal end of the inner tubular member is arranged distal to the second end of the filter portion attached to the distal end of the outer tubular member defining a cylindrical distal extension of the outer tubular member in the expanded configuration.

14. The medical device of claim 11, wherein the filter portion includes an interior surface and an exterior surface, the interior surface facing an inner wall of the outer tubular member and the exterior surface defining an everted distal cavity within the distal end of the outer tubular member in the collapsed configuration, the interior surface defining an interior of the filter portion through which the inner tubular member extends and the exterior surface engaging a body vessel wall in the expanded configuration.

15. The medical device of claim 11, wherein the filter portion includes a plurality of elements defining a plurality of openings sized to allow blood cells to pass through the filter openings and prevent the passage of emboli.

16. The medical device of claim 11, wherein the filter portion includes a porous expandable mesh structure constructed from a material selected from the group consisting of polyester, nylon, Dacron, thorolon, ePTFE, stainless steel, nickel-titanium alloys, and cobalt-base alloys.

17. The medical device of claim 11, further comprising an elongate instrument movable longitudinally within the inner tubular member lumen relative to the inner tubular member and extendible through the proximal and distal openings of the inner tubular member.

18. A method of embolic protection during a medical procedure in a patient'"'"'s body vessel, comprising the steps of:

inserting a medical device into an operative position within the body vessel, the medical device including an outer tubular member and an inner tubular member movable within the outer tubular member, each of the outer and inner tubular members having a proximal end and a distal end and a lumen formed through the proximal and distal ends defining a proximal opening at the proximal end and a distal opening at the distal end, the medical device further comprising a flexible filter portion having a body extending from a first end to a second end, the first end being attached to the distal end of the inner tubular member and the second end being attached to the distal end of the outer tubular member, the filter portion being compressed in an everted state within the distal end of the outer tubular member defining a collapsed configuration during insertion of the medical device;

deploying the filter portion within the body vessel to an expanded configuration wherein the filter portion extends distally from the outer tubular member and is biased to expand radially outward to engage the filter body with an enclosing body vessel wall;

inserting an elongate medical instrument through the lumen of the inner tubular member to perform the medical procedure within the body vessel, wherein the filter portion allows the passage of blood cells to surrounding vessels and prevents emboli from entering surrounding vessels;

removing the elongate medical instrument from within the inner tubular member and the body vessel; and

removing the medical device from within the body vessel.

19. The method of claim 18, wherein the first end of the filter portion attached to the distal end of the inner tubular member is arranged proximal to the distal end of the outer tubular member such that the filter body is everted and defines a distal cavity within the distal end of the outer catheter in the collapsed configuration, wherein deploying the filter portion to the expanded configuration includes moving the inner and outer tubular members relative to one another such that the first end of the filter portion attached to the distal end of the inner tubular member is arranged distal to the second end of the filter portion attached to the distal end of the outer tubular member, the filter body defining a cylindrical distal extension of the outer tubular member in the expanded configuration.

20. The method of claim 18, wherein removing the medical device includes moving the inner and outer tubular members relative to one another to evert the filter portion into the collapsed configuration and proximally retracting the medical device from within the body vessel.